Prevision Policy Clips | LDT Small Entity Compliance Guide Issued By FDA

N of 1? CBER’s Marks Again Overrules Staff In Granting Sarepta DMD Gene Therapy Label Expansion; One Last Regulatory Checkpoint Due In 2027 With ENVISION Trial

Prevision Policy Clips | Sarepta DMD Gene Therapy Label Expansion: CBER Director Marks Again Overrules Staff

Interchangeable For All? Switching Studies May Be Unnecessary For Interchangeable Biosimilar Designations, FDA Says In Draft Guidance

Advisory Committee Listening Session: Industry Mostly Sits Out FDA Feedback Meeting; AbbVie Registers Preference For Separate Documents, Elevated Patient Voice

Prevision Policy Clips | “Interchangeable” Biosimilar Guidance Update: FDA Says Switching Study Standards Have “Evolved”

Prevision Policy Clips | HHS OIG Allows Financial Assistance For Sickle Cell Gene Therapy In June 17 Opinion: Travel, Lodging, Meals, And Associated Expenses

CMMI Accelerated Approval Model May Not Advance “As Fast As Initially Proposed”; Sickle Cell Disease Model Has Received Letters of Intent From States Covering 80% Of SCD Patients

Prevision Policy Clips | CDER Artificial Intelligence Policy Lead Is Tala Fakhouri

CBER Office Of Therapeutic Products Leadership Trying To Increase Consistency Across Gene/Cell Therapy Reviews; Hiring Is Strong For Clinical, CMC Positions

Lilly’s Donanemab Positive FDA Panel Paves Way To Early Alzheimer’s Treatments; Tau Staging Not A Prerequisite

Prevision Policy Clips | FDA Recommends KP.2 Strain Vaccine For 2024-2025 COVID Vaccine Formula, Defying Advisory Committee Recommendation

“Onshoring” Solutions Are Not A Panacea For Drug Shortages, Generic Industry Cautions; Shift Towards Payment For Resiliency As Solution Evident At Duke Policy Meeting

Healthy Disagreement: FDA’s Califf Highlights Value Of Public Debate As Key To Advisory Committee Reform Push; Timeline For Changes Still Unclear

Prevision Policy Clips | Ultragenyx Will File Sanfilippo Syndrome Gene Therapy Application For Accelerated Approval

Prevision Policy Clips | BIOSECURE Act Path To Enactment Looks Less Secure

Prevision Policy Clips | Lilly Donanemab Alzheimer Treatment Gets Strong Efficacy And Benefit/Risk Endorsement

AI Use In Post-Market Safety: CDER Seeks “Mutual Learning” Under New Meeting Program; Up To Nine Projects Per Year Will Be Eligible

340B House GOP Bill Defines “Patient” And Requires Pass-Through Of Discounts; Subcommittee Hearing Features Bipartisan Interest In Fixes But Further Action Is TBD

Lykos’ Bad Trip To FDA Advisory Committee Leads To Rejection Of MDMA For PTSD; Psychedelic Therapeutic Era Not Ready To Begin Yet – But Meeting Offers Guideposts For Future Pathway

Prevision Policy Clips | AI Use For Post-Marketing Surveillance: FDA Accepting Requests For Meetings To Discuss

Lilly’s Donanemab Alzheimer’s mAb Receives Strong Efficacy Assessment From FDA; Potential In Populations Outside Formal Efficacy Trials Noted

Prevision Policy Clips | Calico Life Sciences/AbbVie's Fosigotifator Is Final START Participant

FDA’s VRBPAC Favors Single JN.1 COVID Vaccine Formulation For 2024-2025 Season; Ideal Timing For Strain Selection Remains “Elusive,” Agency Says

Prevision Policy Clips | How Much Is Too Much? AstraZeneca's Imfinzi Lung Cancer sBLA Heads To ODAC July 25